Drug development is a slow and expensive process, with the ultimate step of clinical trials representing one of the costliest and riskiest steps. For a drug to be approved in most countries, particularly the United States, it must pass through a rigorous process of human testing to determine dosage, adverse effects, and efficacy. Only one in ten drugs which commence clinical trials in the U.S. eventually receive approval for human use. The annual cost of conducting clinical trials in the United States is more than 7.4 billion dollars, representing nearly 33% of all R&D expenditures.
One of the slowest and riskiest steps in the clinical trial process itself is the initial enrollment (or recruitment) of patients in the trial. There are approximately 1,000 drugs in Phase II/III trials in the US at any given time, with 1,400 worldwide. Recruitment in clinical trials takes an average of 40 weeks to complete, with 40-50% of the patients screened ultimately deemed inappropriate. It has been estimated that the number of patients needed for clinical trials is doubling every 5 years. Recent drug discovery technologies such as genomics, combinatorial chemistry, and high throughput screening will tend to exacerbate such a need. In a trial, patients must be matched against strict enrollment parameters to ensure proper evaluation of clinical endpoints in the correct patient population. Patients who are inappropriately enrolled for a particular clinical trial present two problems: an improper skewing of adverse effects, dosage, and efficacy; and a slowing of the clinical trial process itself since more patients must be enrolled as the inappropriate patients are ultimately weeded out.
While the Internet and the World Wide Web can facilitate the rapid and global exchange of vast amounts of information, the very nature of such a networked system implicates security concerns, particularly when sensitive information such as patient health records or proprietary drug trial information could be compromised. Nevertheless, the increased availability of medical information on the Internet has resulted in a public eager to try cutting-edge therapies when traditional methods have failed or when no therapy has been approved, as witnessed by the plethora of web sites related to AIDS and cancer information. However, current methods for clinical trial recruitment, including Internet sites dedicated to providing some clinical trial information, have been inefficient. The FDA Modernization Act of 1997 requires pharmaceutical companies to submit trial information to a national registry to promote public access to clinical trials, yet pharmaceutical outfits are unwilling to post sensitive proprietary clinical trial information on the Internet due to competitive or security concerns. An estimated 30% of the ongoing Phase II/III clinical trials ongoing are proprietary for pharmaceutical companies, with 10% of the trials completely confidential, 10% of the trials having confidential inclusion/exclusion criteria, and 10% having confidential site locations. Each pharmaceutical site thus posts only a small percentage of all clinical trials available, often leaving the patient or clinician to perform an exhaustive and often futile search. Patients and clinicians with limited resources or time constraints would hesitate to undertake such searches, particularly given the incomplete offerings at many sites.